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Trial Outcomes & Findings for Cognitive Training and tDCS for Children With FASD (NCT NCT03361293)

NCT ID: NCT03361293

Last Updated: 2021-03-17

Results Overview

Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.

Results posted on

2021-03-17

Participant Flow

Participant milestones

Participant milestones
Measure
Cognitive Training and Active tDCS
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Overall Study
STARTED
20
24
Overall Study
COMPLETED
19
19
Overall Study
NOT COMPLETED
1
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Cognitive Training and Active tDCS
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Overall Study
Lost to Follow-up
0
2
Overall Study
Withdrawal by Subject
1
3

Baseline Characteristics

Cognitive Training and tDCS for Children With FASD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Total
n=38 Participants
Total of all reporting groups
Age, Categorical
<=18 years
19 Participants
n=99 Participants
19 Participants
n=107 Participants
38 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
7 Participants
n=99 Participants
9 Participants
n=107 Participants
16 Participants
n=206 Participants
Sex: Female, Male
Male
12 Participants
n=99 Participants
10 Participants
n=107 Participants
22 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
9 Participants
n=99 Participants
11 Participants
n=107 Participants
20 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=99 Participants
2 Participants
n=107 Participants
8 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Region of Enrollment
United States
19 participants
n=99 Participants
19 participants
n=107 Participants
38 participants
n=206 Participants
Delis Rating of Executive Functioning (D-REF)
69.9 t-score
STANDARD_DEVIATION 9.0 • n=99 Participants
76.3 t-score
STANDARD_DEVIATION 11.7 • n=107 Participants
72.4 t-score
STANDARD_DEVIATION 10.8 • n=206 Participants

PRIMARY outcome

Timeframe: Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.

Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance

Outcome measures

Outcome measures
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
BrainHQ Learning Rate
867.6 milliseconds
Standard Deviation 244.1
861.7 milliseconds
Standard Deviation 264.2

SECONDARY outcome

Timeframe: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

Outcome measures

Outcome measures
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Change in D-KEFS Verbal Fluency - Letter
-0.11 score on a scale
Standard Deviation 2.05
-0.05 score on a scale
Standard Deviation 1.68

SECONDARY outcome

Timeframe: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

Outcome measures

Outcome measures
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Change in D-KEFS Verbal Fluency - Category
-3.68 score on a scale
Standard Deviation 3.93
-3.42 score on a scale
Standard Deviation 3.37

SECONDARY outcome

Timeframe: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

Outcome measures

Outcome measures
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Change in D-KEFS Trail-making - Numbers
1.11 score on a scale
Standard Deviation 3.2
1.37 score on a scale
Standard Deviation 3.2

SECONDARY outcome

Timeframe: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

Outcome measures

Outcome measures
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Change in D-KEFS Trail-making - Letters
1.05 score on a scale
Standard Deviation 3.29
-2.95 score on a scale
Standard Deviation 3.73

SECONDARY outcome

Timeframe: D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

Outcome measures

Outcome measures
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Change in D-KEFS Trail-making - Combined
-1.16 score on a scale
Standard Deviation 6.24
-2.05 score on a scale
Standard Deviation 6.18

SECONDARY outcome

Timeframe: D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section

The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study completion (visit 5), post-intervention. Greater values reflect greater executive functioning impairment.

Outcome measures

Outcome measures
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Delis Rating of Executive Functioning (D-REF)
70.1 t-score
Standard Deviation 11.9
73.2 t-score
Standard Deviation 9.5

SECONDARY outcome

Timeframe: NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)

The Flanker Inhibitory Control and Attention Task from the NIH Toolbox measure inhibitory control and attention. Task performance is in T-scores based on correct items and errors (mean of 50 and a standard deviation of 10). Here, we present difference scores between session 1 (baseline) T-score and 5 (completion) T-score. Greater values represents more change. Positive values represent improvement; negative values represent decline in performance.

Outcome measures

Outcome measures
Measure
Cognitive Training and Active tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 Participants
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Change in Flanker Inhibitory Control and Attention Task
2.05 t-score
Standard Deviation 8.1
3.52 t-score
Standard Deviation 8.92

Adverse Events

Cognitive Training and Active tDCS

Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths

Cognitive Training and Sham tDCS

Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Cognitive Training and Active tDCS
n=19 participants at risk
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training
Cognitive Training and Sham tDCS
n=19 participants at risk
5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
General disorders
Headache
26.3%
5/19 • Number of events 9 • 56 days
21.1%
4/19 • Number of events 4 • 56 days
Skin and subcutaneous tissue disorders
Scalp discomfort
42.1%
8/19 • Number of events 19 • 56 days
36.8%
7/19 • Number of events 11 • 56 days
Musculoskeletal and connective tissue disorders
Neck pain
10.5%
2/19 • Number of events 5 • 56 days
0.00%
0/19 • 56 days
Skin and subcutaneous tissue disorders
Tingling
31.6%
6/19 • Number of events 13 • 56 days
31.6%
6/19 • Number of events 6 • 56 days
Skin and subcutaneous tissue disorders
Itchiness
42.1%
8/19 • Number of events 16 • 56 days
52.6%
10/19 • Number of events 13 • 56 days
General disorders
Sleepiness
63.2%
12/19 • Number of events 31 • 56 days
63.2%
12/19 • Number of events 38 • 56 days
General disorders
Difficulty paying attention
36.8%
7/19 • Number of events 10 • 56 days
26.3%
5/19 • Number of events 7 • 56 days
General disorders
Unusual feelings, attitudes, emotions
10.5%
2/19 • Number of events 2 • 56 days
10.5%
2/19 • Number of events 2 • 56 days
General disorders
Tooth pain
5.3%
1/19 • Number of events 2 • 56 days
0.00%
0/19 • 56 days
Ear and labyrinth disorders
Change in hearing
5.3%
1/19 • Number of events 1 • 56 days
0.00%
0/19 • 56 days
Gastrointestinal disorders
Nausea
10.5%
2/19 • Number of events 8 • 56 days
0.00%
0/19 • 56 days
Musculoskeletal and connective tissue disorders
Twitching / muscle movement
0.00%
0/19 • 56 days
5.3%
1/19 • Number of events 1 • 56 days
General disorders
Dizziness
5.3%
1/19 • Number of events 3 • 56 days
0.00%
0/19 • 56 days
General disorders
Anxiety
10.5%
2/19 • Number of events 7 • 56 days
5.3%
1/19 • Number of events 1 • 56 days
General disorders
Forgetfullness
15.8%
3/19 • Number of events 3 • 56 days
15.8%
3/19 • Number of events 3 • 56 days
Ear and labyrinth disorders
Balance problem
5.3%
1/19 • Number of events 1 • 56 days
10.5%
2/19 • Number of events 2 • 56 days
Nervous system disorders
Change in dominant hand function
5.3%
1/19 • Number of events 1 • 56 days
0.00%
0/19 • 56 days

Additional Information

Jeffrey Wozniak, PhD, LP

University of Minnesota

Phone: 612-273-9741

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place